A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting

• Status: Completed
• Trial end date: 2017-12-19
• Target enrollment: 0
• Participant gender: All

Summary

A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Entecavir

Criteria

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

• Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB.

• Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.

• Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)

Exclusion Criteria:

• Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.

• Any gastrointestinal surgery that could impact upon the absorption of study drug.

• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.